mb-FIX Cranial Stabilization Systems— 510(k) K250423

Substantially Equivalent

Medical Bees GmbH

FDA 510(k) clearance K250423 for mb-FIX Cranial Stabilization Systems, Substantially Equivalent on 2025-11-06. Applicant: Medical Bees GmbH.

Clearance details

Applicant: Medical Bees GmbH
Product code: Code HBL
Advisory panel: Neurology
Date received: 2025-02-14
Decision date: 2025-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emmingen-Liptingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.